Eli Lilly and Company announced the company has been working to facilitate the withdrawal of Lartruvo® (olaratumab) from the market for the treatment of advanced soft tissue sarcoma (STS). Lilly's actions to withdraw Lartruvo from the market follow the failure of the Phase 3 ANNOUNCE clinical trial, in which Lartruvo did not improve survival for patients. Lilly is establishing a program to ensure current patients will have access to Lartruvo with limited interruption after it is withdrawn from the market. The program will be established as allowed by local country regulations.
Lilly is working to ensure that patients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they have been informed of the risks of Lartruvo and the results of the ANNOUNCE study and wish to continue, subject to local laws and regulations. No new patients should receive Lartruvo outside of participation in ongoing clinical trials.
Lilly also is working to establish a program to allow patients who are currently receiving Lartruvo to continue treatment with limited interruption after Lartruvo is withdrawn from the market, subject to local laws and regulations. More information regarding this program will be provided directly to healthcare professionals in the coming weeks.
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"Lilly wants to ensure that patients and physicians feel supported during this important time," said Anne White, president, Lilly Oncology. "Advanced soft tissue sarcoma is a rare and difficult-to-treat cancer. Establishing this program will give patients who are currently taking Lartruvo the opportunity to continue their treatment program uninterrupted."
Sarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. Soft tissue sarcoma (STS) is a complex disease with multiple subtypes, making it hard to diagnose and difficult to treat. According to the American Cancer Society, in 2019, an estimated 12,750 new STS cases will be diagnosed, and more than 5,000 people will not survive their disease in the U.S. alone. For decades, there have been no first-line therapeutic advancements for STS that have improved overall survival (OS).
LARTRUVO is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody that specifically binds PDGFR-α and prevents receptor activation. LARTRUVO exhibits in vitro and in vivo anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFR-α signaling pathway in in vivo tumor implant models.